Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 headache days a month at a severity of 5/10 pain level or greater.
- Willing to not start or stop any new medication to treat or prevent migraines during the six months of the trial.
- History fits the definition of migraine:
- Have a history of episodic headache lasting 4-72 hours with at least 2 of the 4 following: unilateral location, pulsating/throbbing quality, moderate-severe
intensity, aggravation by/causing avoidance of routine physical activity; and
- Have a history of at least one of the following: nausea and/or vomiting, photophobia (seek out a dark room during a headache because that feels better), phonophobia (seek out a quiet environment during a headache because that feels
better).
Exclusion Criteria:
- Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.
- Women who report being currently pregnant or lactating or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception. Acceptable forms include:
- Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants;
- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm);
- Intrauterine device (IUD);
- Total hysterectomy or tubal ligation;
- Abstinence (no sex).
- Allergy or documented contraindication to amide anesthetics (bupivacaine, lidocaine, ropivacaine, prilocaine, mepivacaine, etidocaine or levobupivacaine) or
corticosteroids.
- Previously received peripheral nerve blocks (PNBs).
- Currently anticoagulated.
- Currently receiving Botox for migraine prophylaxis.
- Started on new medication in the prior two months with known migraine-preventive efficacy or planning to start any new medication during the study.
- Currently using opiate medications for pain.
- History of drug or alcohol abuse within the prior two years.
- Have unstable medical or surgical diseases that could impair participation in this study.
- History of craniotomies, burr holes, skull fractures and/or have open skull defects.
- Patients with implanted nerve stimulators or shunts.
- Phobia of needles.
- Active skin or soft tissue infection overlying injection sites.
- Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history on pre-enrollment questionnaire of cluster headache symptoms.
Eligibility last updated 7/24/23. Questions regarding updates should be directed to the study team contact.